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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

smartcorCONTROL — Class IIa MDR by 24sens

MD Atlas
24sens

EUDAMED last updated this device on Jun 25, 2025

smartcorCONTROL

4262353380100UW

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: 24sens
UDI-DI code: 04262353380062
Reference / catalog number: SCC0430

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Manufacturer information

Organization name: 24sens
SRN: AT-MF-000020940
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Jan 23, 2025	Still on market

Device identification

Trade name: smartcorCONTROL
UDI-DI code: 04262353380062
Basic UDI-DI: 4262353380100UW
Reference / catalog number: SCC0430
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The product consists of a database and data processing procedures. It is used to manage and perform computations on the user's transmitted ECG-data. It detects areas that are identified as potential cardiac arrhythmias, such as atrial fibrillation. The backend stores all synchronized recordings and the patient's well-being and activity data during the recording.
Additional information URL: https://ecg.24sens.at/ifu_corcontrol_web-app_doctor_de.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050501CARDIAC OUTPUT MEASUREMENT METERS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

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